Congenital AnomalyNCT03882385
Screening For Critical Congenital Anomalies In NICU And Their Out Come
An observational study of Congenital Anomaly, run by Assiut University.
Trial summary
The congenital malformation (CMF) include disturbance in normal process of organogenesis occurring before birth . The (CMF) are structural ,functional, or (biochemical Molecular) defect presenting at birth. The structural defect resulting from prenatal insult during period of embryogeneses. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Congenital Anomaly
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 19 Mar 2019to 29 Nov 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: study on neonates born with critical congenital anomalies that need intervention in NICU need resuscitation or refere to other specialist
Who may be able to join
- • Cases need resustation and stabilization.
- Congenital anomalies that need admission in NICU eg: impeforated anus , meningiocele, heart disease, tacho osphageal fistula, urinary problems, diaphragmatic hernia, intestinal obstruction, duedodnal obstruction, neural tube defect .
Who cannot join
- All vitally stable cases that don't need NICU admission and all cases not need immediate intervention of congenital anomalies
Trial locations and contacts
No sites are listed yet.
amal ismael, professor dr contact
About this study
Official title: Screening For Critical Congenital Anomalies In NICU And Their Out Come in Assiut Universty
The congenital malformation (CMF) include disturbance in normal process of organogenesis occurring before birth .
- The (CMF) are structural ,functional, or (biochemical Molecular) defect presenting at birth.
- The structural defect resulting from prenatal insult during period of embryogeneses.
- The neonate with congenital malformation have differences in physiology, anatomy, in response to stress.
- The (CMF) are important causes of infant disability , illness, deaths.
- (CMF) classified into mild, moderate, severe and lethal
Read the detailed description
The (CMF) may be structural abnormalities with significant effect on function (e.g) cleft palate .
Or minimal effect on clinical function but may have cosmotic impact (e.g) pre-auricular pit .
In developed countries, outcome of neonatal congenital anomalies is favourable because of availability of antenatal diagnosis, improved surgical skills and technologies, sophisticated neonatal intensive care unit, availability of total parenteral nutrition and adequate staff.
In developing countries, however, neonatal surgery is still fraught with a lot of problems including late presentation and lack of medical facilities and human resources, thereby, making newborn surgery to be associated with unacceptably high morbidity and mortality.
Due to the burden of other neonatal and childhood diseases in developing countries, neonatal surgery is often considered low priority in healthcare budget planning and allocation.
- Effective live , saving medical treatment is available for survival birth defects with functional disorders .
- Neonatal with birth defect may be further referred to appropriate level of medical , surgical facilities .
Risk factors:
- Unknown cause
- Preconception causes are genetic and partially genetic, originating mostly before conception. Birth defects are due to abnormalities of the genetic material-chromosomes and genes including chromosomal abnormalities, single gene defects and multifactorial disorders (which are caused by the interaction of genes and the environment).
- Post-conception causes develop after conception, but before birth. Birth defect is caused by an intra-uterine environmental factor. This includes teratogens that interfere with normal growth and development of the embryo or foetus, mechanical forces that deform the foetus, and vascular accidents that disrupt the normal growth of organs.
- Socioeconomic and demographic factors:
Congenital anomalies are more frequently seen among low income families and countries.
- Maternal age: advanced maternal age increases the risk of chromosomal abnormalities, such as Down syndrome.
- Infections:
Some Maternal infections during pregnancy can increase the risk of birth defects such as:
Rubella infection (German measles-a viral infection) to pregnant mother can result in to miscarriage, deafness, intellectual disability, heart defects and blindness in newborn.
Toxoplasmosis (disease caused by parasite found in soil) infection during pregnancy can cause birth defects such as hearing loss, vision problems and intellectual disability.
Sexually transmitted infections (STIs): such as syphilis, cytomegalovirus can cause serious birth defects.
Zika virus infection: during pregnancy can cause certain birth defects (microcephaly and other abnormalities).
- Environmental factors: Maternal exposure to certain medications, psychoactive drugs, tobacco, radiation and pesticides during pregnancy may increase the risk of congenital anomalies in foetus or neonate.
Working or living near, or in, waste sites, smelters or mines may also be a risk factor.
Certain drugs when taken during pregnancy may cause birth defects; these drugs are called teratogenic drugs (Category 'X' drugs). Categories 'X' drugs are contraindicated during pregnancy. (Drugs are categorized into 5 categories according to the development of adverse effects on the foetus, category A, B, C, D and X.)
- Conditions
- Congenital Anomaly
- Medical subject headings
- Congenital Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
detect number of total babies and percentages of congenital anomalies
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start19 Mar 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion29 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital AnomalyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Tharwat Helmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882385
- Sponsor's protocol ID
- SCCAS
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bassil KL, Collier S, Mirea L, Yang J, Seshia MM, Shah PS, Lee SK; Canadian Neonatal Network. Association between congenital anomalies and area-level deprivation among infants in neonatal intensive care units. Am J Perinatol. 2013 Mar;30(3):225-32. doi: 10.1055/s-0032-1323584. Epub 2012 Aug 9.
PubMed 22879358
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening For Critical Congenital Anomalies In NICU And Their Out Come in Assiut Universty
- ClinicalTrials.gov ID
- NCT03882385
- Acronym / sponsor ID
- SCCAS
- Conditions
- Congenital Anomaly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 Mar 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 29 Nov 2020 (estimated)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The congenital malformation (CMF) include disturbance in normal process of organogenesis occurring before birth .
- The (CMF) are structural ,functional, or (biochemical Molecular) defect presenting at birth.
- The structural defect resulting from prenatal insult during period of embryogeneses.
- The neonate with congenital malformation have differences in physiology, anatomy, in response to stress.
- The (CMF) are important causes of infant disability , illness, deaths.
- (CMF) classified into mild, moderate, severe and lethal
Detailed description
The (CMF) may be structural abnormalities with significant effect on function (e.g) cleft palate .
Or minimal effect on clinical function but may have cosmotic impact (e.g) pre-auricular pit .
In developed countries, outcome of neonatal congenital anomalies is favourable because of availability of antenatal diagnosis, improved surgical skills and technologies, sophisticated neonatal intensive care unit, availability of total parenteral nutrition and adequate staff.
In developing countries, however, neonatal surgery is still fraught with a lot of problems including late presentation and lack of medical facilities and human resources, thereby, making newborn surgery to be associated with unacceptably high morbidity and mortality.
Due to the burden of other neonatal and childhood diseases in developing countries, neonatal surgery is often considered low priority in healthcare budget planning and allocation.
- Effective live , saving medical treatment is available for survival birth defects with functional disorders .
- Neonatal with birth defect may be further referred to appropriate level of medical , surgical facilities .
Risk factors:
- Unknown cause
- Preconception causes are genetic and partially genetic, originating mostly before conception. Birth defects are due to abnormalities of the genetic material-chromosomes and genes including chromosomal abnormalities, single gene defects and multifactorial disorders (which are caused by the interaction of genes and the environment).
- Post-conception causes develop after conception, but before birth. Birth defect is caused by an intra-uterine environmental factor. This includes teratogens that interfere with normal growth and development of the embryo or foetus, mechanical forces that deform the foetus, and vascular accidents that disrupt the normal growth of organs.
- Socioeconomic and demographic factors:
Congenital anomalies are more frequently seen among low income families and countries.
- Maternal age: advanced maternal age increases the risk of chromosomal abnormalities, such as Down syndrome.
- Infections:
Some Maternal infections during pregnancy can increase the risk of birth defects such as:
Rubella infection (German measles-a viral infection) to pregnant mother can result in to miscarriage, deafness, intellectual disability, heart defects and blindness in newborn.
Toxoplasmosis (disease caused by parasite found in soil) infection during pregnancy can cause birth defects such as hearing loss, vision problems and intellectual disability.
Sexually transmitted infections (STIs): such as syphilis, cytomegalovirus can cause serious birth defects.
Zika virus infection: during pregnancy can cause certain birth defects (microcephaly and other abnormalities).
- Environmental factors: Maternal exposure to certain medications, psychoactive drugs, tobacco, radiation and pesticides during pregnancy may increase the risk of congenital anomalies in foetus or neonate.
Working or living near, or in, waste sites, smelters or mines may also be a risk factor.
Certain drugs when taken during pregnancy may cause birth defects; these drugs are called teratogenic drugs (Category 'X' drugs). Categories 'X' drugs are contraindicated during pregnancy. (Drugs are categorized into 5 categories according to the development of adverse effects on the foetus, category A, B, C, D and X.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- study on neonates born with critical congenital anomalies that need intervention in NICU need resuscitation or refere to other specialist
Key inclusion criteria (2 listed)
- • Cases need resustation and stabilization.
Key exclusion criteria (1 listed)
- All vitally stable cases that don't need NICU admission and all cases not need immediate intervention of congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
detect number of total babies and percentages of congenital anomalies
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 22879358Bassil KL, Collier S, Mirea L, Yang J, Seshia MM, Shah PS, Lee SK; Canadian Neonatal Network. Association between congenital anomalies and area-level deprivation among infants in neonatal intensive care units. Am J Perinatol. 2013 Mar;30(3):225-32. doi: 10.1055/s-0032-1323584. Epub 2012 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
amal ismael, professor dr contact
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Anomaly, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira tharwat helmy, student (01206119729 ext. 01226211190, totonono744@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect number of total babies and percentages of congenital anomalies (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.